Inter Partes Review of USP 8,291,904
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`In re Inter Partes Review of:
`U.S. Patent No. 8,291,904
`Issued: Oct. 23, 2012
`Application No.: 13/493,493
`U.S. Filing Date: June 11, 2012
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`For: Gas Delivery Device and System
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`FILED VIA PRPS
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`DECLARATION OF WARREN P. HEIM, P.E. IN SUPPORT OF
`PATENT OWNER’S RESPONSE TO PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 8,291,904
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`Ex. 2021-0001
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`

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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`TABLE OF CONTENTS
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`Page
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`I.
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`
`II.
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`INTRODUCTION AND QUALIFICATIONS ............................................... 1
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`UNDERSTANDING OF THE GOVERNING LAW ..................................... 8
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`A. A Person of Ordinary Skill in the Art ................................................... 8
`B.
`Anticipation ........................................................................................... 9
`C.
`Obviousness ......................................................................................... 10
`D.
`Claim Construction ............................................................................. 13
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`
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` MATERIALS RELIED UPON IN FORMING OPINIONS ......................... 14 III.
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`IV.
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` OVERVIEW OF THE ’904 PATENT .......................................................... 14
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`V.
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` OVERVIEW OF ALLEGED PRIOR ART .................................................. 18
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`A.
`B.
`C.
`D.
`E.
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`Bathe ’083 ........................................................................................... 18
`Peters ’510 ........................................................................................... 22
`French Patent Publication No. 2 917 804 (“FR ’804”) ....................... 30
`The IR Standard ................................................................................... 35
`Lebel ’533 ............................................................................................ 36
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`VI.
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` LEVEL OF ORDINARY SKILL IN THE ART ........................................... 37
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` NO DELIVERY DEVICES OFFERED FOR SALE .................................... 38 VII.
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`A.
`B.
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`INOmax DSIR® NO Delivery Systems.............................................. 39
`Other NO Delivery Systems ................................................................ 39
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` MOTIVATION TO COMBINE .................................................................... 41 VIII.
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`A.
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`The Motivation of a Person of Ordinary Skill in the Art
`Designing Medical Devices ................................................................ 41
`The Influence of MAUDE and FDA Guidance .................................. 46
`B.
`C. Motivation to Combine Bath ’083 and Peters ’510 ............................ 53
`D. Motivation to Combine FR ’804 with Bathe ’083 and/or Peters
`’510 ...................................................................................................... 56
`E. Motivation to Combine the IR Standard with the Other Cited
`References ........................................................................................... 64
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`i
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`Ex. 2021-0002
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`

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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`IX.
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` COMPARISON OF ’904 CLAIMS TO ASSERTED
`COMBINATIONS ......................................................................................... 65
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`X.
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`CONCLUSION .............................................................................................. 70
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`ii
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`Ex. 2021-0003
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`

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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`I, Warren P. Heim, P.E. resident of Boulder, Colorado, hereby declare as
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`follows:
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`I.
`1.
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`INTRODUCTION AND QUALIFICATIONS
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`I have been retained by INO Therapeutics, LLC (“INO”) to provide my
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`opinions concerning certain claims of U.S. Patent No. 8,291,904 (the “’904
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`patent”) in support of INO’s Response to the Institution of Inter Partes
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`Review of the ’904 patent. I have not previously been employed or retained
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`by INO in any capacity.
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`2.
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`I am a Registered Professional Engineer with three college degrees: A.B.
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`1973 with a major in engineering from Dartmouth College, B.E. 1974 and
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`M.E. 1975, both from Dartmouth College’s Thayer School of Engineering.
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`3.
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`I have been a product development consultant or engineer for the medical
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`device and energy industries since 1975. In my projects I have designed
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`mechanical, electromechanical, and electronic products and been the system
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`architect
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`for medical
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`devices
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`that
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`incorporated mechanical,
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`electromechanical, electronic, and software subsystems.
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`4. My medical device experience includes infusion pumps when I was
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`employed between 1982 and 1987 by Valleylab when it is was a unit of
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`Pfizer. I worked on new products and improving existing products including
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`remote communication and control between pumps and computers at nursing
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`1
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`Ex. 2021-0004
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`stations using wired connections. The precision and accuracy of the pumps
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`made them particularly well suited to deliver medications to neonates.
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`5.
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`I was one of the founders and the president of The Larren Corporation
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`(“Larren”), a contract medical device product development firm that was
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`eventually sold to Battelle Memorial Institute after Battelle approached us
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`about purchasing the firm.
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`6.
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`Among the projects at Larren in which I was involved was a locator for
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`endotracheal tubes that was recognized for design excellence as a finalist in
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`the Medical Device and Diagnostic Industry Medical Device Excellence
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`Awards.
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`7.
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`As a product development consultant I have managed and been an engineer
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`on many projects including ambulatory infusion pumps, cardiac monitors,
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`hemodialysis systems, catheters, and electrosurgical instruments.
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`8.
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`These projects
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`frequently
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`involved multiple microprocessor CPUs
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`exchanging and comparing data. One project for an automated assembly
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`line had over 15 control modules with CPUs using communication protocols
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`that I developed and implemented as the system architect and lead engineer.
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`9.
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`Another project was a hemodialysis system for which I was the system
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`architect and lead engineer that had multiple microprocessor CPUs
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`exchanging information, including using radio telemetry to an external
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`2
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`Ex. 2021-0005
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`control module and radio telemetry to a remote data warehouse. That
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`product included over a dozen sensors and valves that automatically routed
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`fluids based on control sequences that I developed. I also led the software
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`team on that project.
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`10. Projects have included identifying compounds in containers so that
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`microprocessor CPUs could establish the presence of the correct substances.
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`One project that mixed liquid compounds used bar codes and another one
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`used RFID tags for product identification. I was the product architect and
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`lead engineer on both projects.
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`11. On other projects I have worked with the flow and control of liquids and
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`gases. I have worked on multiple projects that pumped liquids in which the
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`systems incorporated detecting the presence of gas bubbles for both patient
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`safety and to avoid having the gas compromise product performance. The
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`gas detection projects included multiple infusion pumps and a hemodialysis
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`system.
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`12.
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`I have worked on a variety of projects that required sensing and controlling
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`gas flows. One project involved controlling compressed gas flow into a
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`surgical instrument to atomize saline precisely. Another project carefully
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`controlled gas flow and precisely measured liquid flow out of many surgical
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`instruments designed to aspirate liquid from the surgical site. For both of
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`3
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`Ex. 2021-0006
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`those projects I set up the pressure regulators and valves that managed the
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`gas flow. On another project I designed a flow circuit, including an
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`electrically actuated multi-port valve that reversed the direction of air flow
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`to a precision pneumatic cylinder in a test fixture I designed to measure the
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`performance of sprayers. I have also designed air atomizing sprayers in
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`which the flow field of the gas was critical to the geometry of the resulting
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`spray pattern.
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`13.
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`I have developed multiple fluid flow computer models to evaluate the
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`dynamic performance of medical devices. In one case the model identified a
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`serious flaw in a product concept caused by the interaction of gas
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`compression and the fluid dynamics of a liquid intended to be delivered to a
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`patient.
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`14.
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`I have done many thermodynamic and heat transfer calculations associated
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`with gases. These models included both large scale models of industrial
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`processes as well as small scale (fractions of an inch) models of medical
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`devices.
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`15. My product development consulting experience includes working with large
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`companies, such as Baxter Healthcare, Johnson & Johnson, Abbott
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`Laboratories, Medtronic, St. Jude Medical, and 3M, as well as small
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`companies.
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`4
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`Ex. 2021-0007
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`16. My medical device product development activities have led to my being the
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`inventor on over 25 United States patents with other patent applications
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`having been filed and pending. The subject matter of the patents includes
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`mechanisms, electronics, and signal processing, as well as fluid flow.
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`17.
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`I am an owner and the manager of Team Medical, LLC, a medical device
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`product development and R&D company.
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`18. Team Medical provides contract medical device development and R&D
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`services and also conducts its own internal R&D. The services provided
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`include engineering design, product testing, and support complying with
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`U.S. medical device regulations. Team Medical also provides expert
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`services supporting litigation.
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`19. As part of Team Medical’s contract product development I have evaluated
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`incorporating 1-wire memory devices into disposable surgical instruments.
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`This technology is disclosed in the ’904 patent.
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`20. As another part of Team Medical’s contract product development I have
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`designed and reviewed mechanical, electronic, and software designs of
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`medical devices.
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`21. Team Medical’s internal R&D projects focus on medical devices. In some
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`cases technology has been licensed to other companies and technology has
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`also been sold. For example, in late 2014 a technology for which a patent
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`5
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`Ex. 2021-0008
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`application has been filed was sold to an outside firm that has since had an
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`IPO.
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`22.
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`Internal R&D projects include making and testing prototypes in Team
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`Medical’s laboratories that include an electronics lab, a machine shop and
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`assembly lab, and a coatings and prototype manufacturing lab that has both
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`laminar flow and fume hoods and custom multi-axis robotic manufacturing
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`systems. Those systems employ communications between sensors, motor
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`control modules, and control panels that I designed and built. The machine
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`shop and assembly lab has a specialized multi-axis automated machining
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`station that I designed and built. That machining station has multiple
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`sensors and communication between control modules with CPUs.
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`23. One of Team Medical’s surgical
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`instrument
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`inventions won
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`the
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`“Commercial Product of the Year” award at the DaVinci Institute’s 2006
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`Colorado Inventor Showcase.
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`24. My design experience includes mechanical, electronic, and software
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`engineering as well as developing control and analysis algorithms that
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`integrate mechanical and electronic systems and computers.
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`25.
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`I have worked with the United States Food and Drug Administration,
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`including preparing 510(k) submission packages that were cleared for
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`marketing by FDA.
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`6
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`Ex. 2021-0009
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`26. As part of the 510(k) regulatory submittal process I have selected the
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`predicate devices to be used and the characteristics used to establish that
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`substantial equivalence exists.
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`27. As part of the 510(k) regulatory submittal process I have identified and used
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`FDA recognized standards.
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`28. My 510(k) activities have
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`included (1) setting up and managing
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`biocompatibility studies, (2) setting up, managing, and conducting
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`performance tests of new devices and predicate devices, (3) employing
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`standards-based tests, (4) preparing technical sections of 510(k) submission
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`documents, (5) preparing the labeling sections of 510(k) submission
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`documents, and revising 510(k) submission documents based on discussions
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`I have had with FDA reviewers.
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`29.
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`In summary, I have broad experience
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`in medical device product
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`development and R&D, including 510(k) regulatory submittals, that
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`qualifies me to evaluate the technology in the patents and alleged prior art
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`that are the subject of the matter at hand. My experience includes working
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`with many dozens of engineers and designers as well as product managers,
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`regulatory specialists, and executives in a variety of medical device
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`companies, which enables me to understand the skill of medical device
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`engineers representative of those having ordinary skill.
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`7
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`Ex. 2021-0010
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`30. Other information regarding my background and experience, including a list
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`of issued United States patents is in my curriculum vitae. (Ex. 2022, C.V. of
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`Warren P. Heim.)
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`31. My work in this matter is being billed at my standard consulting rate of $500
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`per hour. My compensation is not in any way contingent upon the outcome
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`of any Inter Partes Review. I have no financial or personal interest in the
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`outcome of this proceeding or any related litigation.
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` UNDERSTANDING OF THE GOVERNING LAW
`II.
`32.
`I am not an attorney. Counsel has provided me with information relating to
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`the legal standards relevant to the issues presented in this Inter Partes
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`Review. Included below is my understanding of those standards.
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`A. A Person of Ordinary Skill in the Art
`I understand that my analysis of the claims of a patent are judged from the
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`33.
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`perspective of a hypothetical construct involving “a person of ordinary skill
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`in the art.” The “art” is the field to which a patent is related. I understand
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`that the field of the ’904 patent is medical device technology and, in
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`particular, medical gas delivery devices.
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`34.
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`I further understand that the characteristics of a hypothetical person of
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`ordinary skill in the art of the ’904 patent at the time of the claimed
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`invention, depend on several considerations, including the type of problems
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`8
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`Ex. 2021-0011
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`encountered in the art, the prior art solutions to those problems, the rapidity
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`with which innovations are made, the sophistication of the technology, and
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`the educational level of active workers in the field.
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`B. Anticipation
`I understand that a patent claim is anticipated only if a single prior art
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`35.
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`reference discloses each and every element of the claim, arranged as set
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`forth in the claim. If a reference fails to expressly disclose one or more
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`elements of the patent claim, the claim is anticipated only if the missing
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`elements are disclosed inherently in the reference. An element is disclosed
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`inherently only if it is necessarily present in the process or product described
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`in the prior art reference. I further understand that inherency may not be
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`established by a possibility, or even a probability, that a certain result may
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`arise from a given set of circumstances.
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`36.
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`I further understand that to anticipate a patent claim, a prior art reference
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`must be enabling. That is, the reference must provide sufficient information
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`to allow one skilled in the art to practice what is disclosed without undue
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`experimentation.
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`37.
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`I further understand that Petitioner has not identified any anticipatory prior
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`art references at issue in this proceeding.
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`9
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`Ex. 2021-0012
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`C. Obviousness
`I understand that a patent claim is invalid for obviousness only if the
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`38.
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`invention described in the claim would have been obvious to a person of
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`ordinary skill in the art at the time the invention was made. I understand that
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`the time that the invention was made typically refers to the date upon which
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`the application that led to the patent at issue was filed with the Patent Office.
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`Here, I have been asked to assume that the pertinent time is January 2011. I
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`understand that the fundamental question in an obviousness analysis is
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`whether the claimed invention would have been obvious to a person of
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`ordinary skill in the art, taking into account (1) the scope and content of the
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`prior art, (2) the differences between the prior art and the claimed invention,
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`(3) the level of ordinary skill in the art, and (4) any secondary considerations
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`of non-obviousness.
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`39.
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`I understand that multiple references can be combined with one another, or
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`with the knowledge of a person of ordinary skill in the art, to render a claim
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`obvious. I also understand that obviousness is not established simply
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`because all of the elements of a patent claim can be found in the prior art,
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`but that there must be a specific reason that would have prompted a person
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`of ordinary skill in the relevant field to combine the elements in the way the
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`claimed new invention does.
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`10
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`Ex. 2021-0013
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`

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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`40.
`
`I understand that the Supreme Court has provided further guidance
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`concerning the obviousness analysis. Specifically, I understand that
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`obviousness is not established by simply combining previously known
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`elements from the prior art. A patent composed of several elements is not
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`proved obvious merely by demonstrating that each of its elements was,
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`independently, known in the prior art. An invention is unpatentable as
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`obvious only if the differences between the patented subject matter and the
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`prior art would have been obvious at the time of invention to a person of
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`ordinary skill in the art.
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`41.
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`I understand that it will often be necessary to look to interrelated teachings
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`of multiple patents, the effects of demands known to the design community
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`or present in the marketplace, and the background knowledge possessed by a
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`person having ordinary skill in the art in order to determine whether there
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`was an apparent reason to combine the known elements in the fashion
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`claimed by the patent at issue. I understand that any need or problem known
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`in the field of endeavor at the time of invention and addressed by the patent
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`can provide a reason for combining the elements in the manner claimed. I
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`understand that when a work is available in one field of endeavor, design
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`incentives and other market forces can prompt variations of it, either in the
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`same field or a different one. I understand that the combination of familiar
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`11
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`Ex. 2021-0014
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`elements according to known methods may be obvious when it does no more
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`than yield predictable results. I also understand that a claim is not invalid as
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`obvious if it is more than the predictable use of prior art elements according
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`to their established functions.
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`42.
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`I understand that if the prior art teaches away from combining known
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`elements in the manner claimed by the invention at issue, discovering a
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`successful way to combine them is less likely to be obvious. I understand
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`that similar subject matter may not be sufficient motivation for a person of
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`skill in the art to combine references if the references have conflicting
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`elements.
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`43.
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`I understand that a motivation to conduct further testing or research that may
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`lead to the claimed invention does not necessarily render a claim obvious. I
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`understand that an invention is not necessarily rendered obvious simply
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`because it was obvious to try a certain combination.
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`44.
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`I understand that obviousness of a patent cannot properly be established
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`through hindsight, and that elements from different prior art references, or
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`different embodiments of a single prior art reference, cannot be selected to
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`create the claimed invention using the invention itself as a roadmap. I
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`understand that the claimed invention as a whole must be compared to the
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`prior art as a whole, and courts must avoid aggregating pieces of prior art
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`12
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`Ex. 2021-0015
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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`through hindsight which would not have been combined absent the
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`inventors’ insight.
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`45.
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`I understand that secondary considerations of non-obviousness must be
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`considered in addition to the primary considerations of the scope and content
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`of the prior art, the differences between the prior art and the claims at issue,
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`and the level of ordinary skill in the art. Counsel has also informed me that
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`secondary considerations of non-obviousness may include commercial
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`success of products or processes using the invention, long felt need for the
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`invention, failure of others to make the invention, industry acceptance of the
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`invention, licensing of the invention, copying of the invention by others,
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`initial skepticism aimed at the invention, statements of acclaim for the
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`invention, and unexpected results achieved by the invention.
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`D. Claim Construction
`I understand that the parties have not identified any claim construction issues
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`46.
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`in dispute in this proceeding. However, as a general matter, I understand
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`that the words of a claim are generally given their ordinary and customary
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`meaning, which is the meaning that the term would have to a person of
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`ordinary skill in the art as of the effective filing date of the patent application
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`(January 2011).
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`13
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`Ex. 2021-0016
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`

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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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` MATERIALS RELIED UPON IN FORMING OPINIONS
`III.
`47.
`In forming my opinions, I have relied on the ’904 patent’s claims,
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`specification, and file history, the prior art exhibits to the Petition for Inter
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`Partes Review of the ’904 patent, the Decision of Institution of Inter Partes
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`Review of the ’904 patent, the declaration of Dr. Stone and exhibits thereto,
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`the deposition testimony of Dr. Stone and exhibits thereto, search results
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`from the MAUDE database, portions of 21 C.F.R. §§ 814 and 820 et seq.,
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`the translated brochure for the Praxiar NOMIX device, the PrinterNOx
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`operating manual, a letter from Praxair to Ikaria, the translated brochure for
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`the Air Liquide Opti Kinox Station, any other materials cited in this
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`declaration, and my own experience, expertise, and knowledge of the person
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`of ordinary skill in the art in the relevant timeframe (January 2011).
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` OVERVIEW OF THE ’904 PATENT
`IV.
`48. The ’904 patent describes a gas delivery device, including a valve and a
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`circuit, for use in a gas delivery system for administering therapeutic gas,
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`such as nitric oxide (“NO”), to a patient. (Ex. 1001 at 1:14-16, 49-56.) As
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`shown in the ’904 patent’s FIG. 1, the gas delivery system has a valve
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`assembly 100 attached to a gas source 50, a control module 200 that controls
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`the gas delivery to a patient, and a gas delivery mechanism, such as a
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`ventilator 400:
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`14
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`Ex. 2021-0017
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`

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`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`(Id. at 6:4-14, FIG. 1.)
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`
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`49. The valve assembly is made up of a valve and a circuit with a valve memory
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`in communication with a valve processor and a valve transceiver. (Id. at
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`1:52-56.) The valve memory stores gas data such as the gas composition
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`(e.g., NO), gas concentration, expiration date, and other information. (Id. at
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`7:18-21.) The valve transceiver communicates with a central processing unit
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`(“CPU”) in the control module, for example, via wireless optical line-of-
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`sight signals (such as infrared (“IR”) signals) that are transmitted between
`
`
`
`
`
`15
`
`Ex. 2021-0018
`
`

`
`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`
`the valve transceiver and a CPU transceiver. (Id. at 1:56-63, 2:25-27, 2:51-
`
`62.)
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`50. The ’904 patent explains that the communication between the valve and
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`CPU transceivers solves problems with known gas delivery devices existing
`
`at the time of the invention. (Id. at 1:21-45.) The patent states that, while
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`known computerized gas delivery devices were capable of tracking patient
`
`and treatment information, those devices did not communicate with other
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`components of the system (e.g., the valve attached to the gas source) to
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`confirm that the correct, unexpired gas was being supplied to the device.
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`(Id. at 1:28-36.) The goal of the ’904 patent is providing a safety
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`mechanism absent in the prior art.
`
`51. The ’904 patent discloses a technologically complex invention. The
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`specification and claims are intended for a relatively sophisticated audience
`
`of medical device development engineers. The complexity of the invention
`
`makes it difficult for a lay person to understand without the guidance of
`
`someone with some expertise in the field of medical device development.
`
`52. Claim 1 of the ’904 patent recites:
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`1. A valve assembly to deliver a gas comprising NO from
`a gas container containing the gas comprising NO, the
`valve assembly comprising:
`
`
`
`
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`16
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`Ex. 2021-0019
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`

`
`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`
`a valve attachable to the gas container containing the
`gas comprising NO, the valve including an inlet
`and an outlet in fluid communication and a valve
`actuator to open or close the valve to allow the gas
`comprising NO through the valve to a control
`module;
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`a circuit supported within the valve assembly and
`disposed between the actuator and a cap, the
`circuit including:
`
`a valve memory to store gas data comprising gas
`concentration in the gas container and
`
`a valve processor and a valve transceiver in
`communication with the valve memory to send
`wireless optical
`line-of-sight
`signals
`to
`communicate the gas data to the control module
`that controls gas delivery to a subject; and
`
`in
`the actuator and
`input disposed on
`a data
`communication with said valve memory, to permit
`a user to enter the gas data into the valve memory.
`
`(Id. at 16:44-63.)
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`53. The claim element “a valve processor and a valve transceiver in
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`communication with the valve memory to send and receive wireless optical
`
`line-of-sight signals to communicate the gas data to the control module that
`
`
`
`
`
`17
`
`Ex. 2021-0020
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`

`
`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`
`controls gas delivery to a subject” is novel and unique to the ’904 patent.
`
`(Id. at 16:56-60.) I have not observed parts of a system communicating with
`
`other parts of that system in any existing gas delivery devices, nor have I
`
`seen such communication disclosed in the prior art.
`
`54. Furthermore, the claim element of communicating “the gas data” which
`
`comprises “gas concentration in the gas container” facilitates the a novel and
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`unique safety check. (Id. at 16:54-60.) I have not observed this safety check
`
`in any existing gas delivery devices, nor have I seen this safety check
`
`disclosed in any of the alleged prior art I have reviewed.
`
` OVERVIEW OF ALLEGED PRIOR ART
`V.
`55.
`I understand that the Board instituted Inter Partes Review of the ’904 patent
`
`on September 22, 2015 on the following grounds: Claims 1-8 and 11-16 as
`
`obvious over Bathe, Peters, FR ’804, and the IR Standard, and Claims 3 and
`
`4 as obvious over Bathe, Peters, FR ’804, the IR Standard, and Lebel, and
`
`Claims 9 and 10 as obvious over Bathe, Peters, FR ’804, the IR Standard,
`
`and Durkan.
`
`A. Bathe ’083
`56. Bathe ’083 teaches a nitric oxide delivery system that controls the flow rate
`
`and concentration of nitric oxide delivered to a patient by employing sensors
`
`
`
`
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`18
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`Ex. 2021-0021
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`

`
`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
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`and valves connected to a CPU along with data input to the CPU by a user.
`
`(Ex. 1005 at FIG 1, 3:59-67, 4:51-53, 5:13-6:54, 7:62-66, 8:12-27.)
`
`
`
`57. The NO gas supplied is a mixture of nitric oxide and nitrogen and comes in
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`cylinders pressurized to about 2000 psi having a concentration between 800
`
`and 2000 ppm. Bathe ’083 teaches reducing the pressure of the NO gas
`
`using a regulator 12 and the reduced pressure gas is fed into on-off shut-off
`
`valve 14 (Id. at FIG 1, 3:61-67.) On-off shut-off valve 14 is controlled by
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`CPU 56 which also controls purge valve 20 and proportional valve 24. (Id.
`
`at 6:16-20.)
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`58. The CPU has flow rate data and gas concentration data from breathing gas
`
`flow transducer 46, NO concentration in the NO/nitrogen mixture from NO
`
`
`
`
`
`19
`
`Ex. 2021-0022
`
`

`
`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`
`sensor 65, and the desired NO concentration to deliver to the patient from
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`data entered by a user into input device 58. (Id. at 6:43-3.) Bathe ’083
`
`teaches that the user can select the desired concentration of NO to be
`
`delivered by the user using an input device such as a keyboard. (Id. at 6:29-
`
`33.)
`
`59. The CPU calculates how much NO to deliver and controls proportional
`
`valve 24 appropriately. (Id. at 7:6-12.) As needed, such as the user desiring
`
`very low concentrations of NO being delivered to the patient, the CPU also
`
`controls proportional valve 18 to deliver NO concentrations below those
`
`achievable using only proportional valve 24. (Id. at 7:62-67.)
`
`60.
`
`If the NO level reaches dangerous levels, as determined by measurements
`
`made by gas sensing bench 52, the CPU can discontinue NO delivery to the
`
`patient by shutting off valve 14 or by automatically reducing the NO level.
`
`(Id. at 8:1-12.)
`
`61. Bathe ’083 also teaches using alarms to alert the user of conditions needing
`
`attention to protect the patient, such as excess concentrations of NO or a
`
`decrease in oxygen to the patient below a predetermined level or an increase
`
`in nitrogen dioxide (as opposed to nitrogen oxide) above a predetermined
`
`level. The system may also automatically take control steps to alleviate
`
`unsafe conditions that it senses. (Id. at 3:1-4, 14-25.)
`
`
`
`
`
`20
`
`Ex. 2021-0023
`
`

`
`Declaration of Warren P. Heim, P.E. in Support of Patent Owner’s Response to
`Petition for Inter Pa